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Regulatory Affairs Manager
4 months ago
Our client, a leading independent pharmaceutical company who have a wide range of specialist medications and generics, have an opportunity for an experienced EU/ UK Regulatory team leader to join their team in Hampshire.
Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below.
As Regulatory Affairs manager, you will:
- Leading a small team, handling the regulatory activity across a large portfolio of medicine and licences across therapy areas including Oncology, CNS, respiratory
- Working with EU, UK, and RoW regulatory bodies; as the subject matter expert for Medicines; Medical Devices and related ISO activities (including ISO13485 and ISO14971); Controlled Drugs; Nutritional Products; In Vitro Diagnostic Devices; Biocidal Products
- Review and support for submission of new product dossiers and technical files – both own development, in-licensed and out-licensed and all aspects of regulatory lifecycle maintenance for existing products
- Author technical documentation, including EU eCTD dossier sections, technical file documents and product artwork, for alignment with applicable regulations and guidance and assessing suitability for submission where appropriate.
- Regulatory Strategy and Scientific Writing
- Finial signatory on artwork and labelling material
To be considered for the role of Regulatory Affairs Manager, you will have the following:
- Minimum of 5 years of Regulatory Affairs experience in a relevant pharma company
- Educated to degree level in a relevant life science discipline
- Must have previous line management experience - ideally 3 or more direct reports to meet criteria
- Worked in a broad role, covering R&D projects and CMC knowledge- a project manager approach
- Must be commercially astute, with regular interactions with regulators and external stakeholders
- Must have proven experience with EU and UK regulations for Pharmaceutical products or Combination products.
- Valid right to work in the UK.
Due to the nature of the team, this person will be required at the Hampshire office at least 2 times a week. Hybrid working.
